Compare Polyethylene Glycol and Sodium Picosulfate Alone or Combined

Dalin Tzu Chi General Hospital

Status: Unknown

Conditions: Bowel Preparation

Treatments: Drug: PEG plus SPMC; Drug: SPMC; Drug: PEG

Study type: Interventional

Funder types: Other

Identifiers

NCT03965182

A10801001

Details and patient eligibility

About

Sodium picosulfate/magnesium citrate (SPMC) is generally better tolerated than PEG, its cleansing effect remains uncertain. While most studies showed SPMC was non-inferior to PEG, some studies reported that SPMC was less effective than PEG. To improve the bowel cleansing effect of SPMC, splitting the dose by using one sachet the evening before colonoscopy and the other sachet 4 to 5 hours before colonoscopy in the morning, has been proposed.Adding bisacodyl to the regimen also has been shown to be helpful. Some side effects, such as hyponatremia, dehydration and sleep disturbance, were reported to be more commonly associated with SPMC than with PEG.

To enhance the efficacy and reduce the side effects, two studies have evaluated the combination of SPMC and PEG, with conflicting results.The effect of combining PEG and SPMC should be best appreciated with head-to-head comparison with PEG and SPMC alone at the same time.

Therefore we designed this head-to-head comparison study for 2 L PEG, 1L PEG plus one sachet of SPMC and 2 sachet of SPMC, all with split-dose and the addition of 10 ml bisacodyl. Our hypothesis is the bowel cleansing effect of the combination regimen was not inferior to PEG alone. The tolerability, acceptability and side effects of the 3 regimen will also be evaluated.

Patients will be randomly assigned to either PEG, PEG plus SPMC or SPMC group, in a 1:1:1 ratio using a computer-generated sequence. The treatment allocation will be concealed and revealed by non-research medical personnel at the screening visit.

Enrollment: 600 estimated patients

Sex: All

Ages: 20 to 80 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Eligible patients will include those anticipated to undergo colonoscopy, aged 20 to 80 at the time of enrollment.

Exclusion criteria

• previous colon resection, gastrointestinal obstruction, ileus, intestinal perforation, toxic megacolon, active stage of inflammatory bowel disease, congestive heart failure (New York Heart Association Class III or IV),acute cardiovascular disease, uncontrolled arterial hypertension (systolic pressure >170 mmHg, diastolic pressure>100 mmHg), severe liver cirrhosis (Child-Pugh score C) or renal failure (creatinine clearance<30 mL/minute) or any allergy to, PEG, or sodium picosulfate solution, phenylketonuria, and glucose-6-phosphate dehydrogenase deficiency.

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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600 participants in 3 patient groups

PEG group

Active Comparator group

Description:

Patients in the PEG group were instructed to take the first sachet of PEG at 19:00 hours the day before colonoscopy and the second one at 06:00 hours on the morning of the day of colonoscopy.

Treatment:

Drug: PEG

PEG plus SPMC group

Active Comparator group

Description:

Patients in the PEG plus SPMC group will be instructed to take the SPMC sachet at 19:00 hours the day before colonoscopy and the PEG sachet at 6:00 hours on the morning of the day of colonoscopy.

Treatment:

Drug: PEG plus SPMC

SPMC group

Active Comparator group

Description:

Patients in the SPMC group were instructed to take the first sachet of SPMC at 19:00 hours the day before colonoscopy and the second one at 06:00 hours on the morning of the day of colonoscopy.

Treatment:

Drug: SPMC